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Pharmaceuticals
Special Issues
Automation of Radiolabeling Processes
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Automation of Radiolabeling Processes

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Radiopharmaceutical Sciences".

Deadline for manuscript submissions: closed (1 August 2023) | Viewed by 2340

Special Issue Editor

Dr. Sarah Spreckelmeyer

E-Mail Website
Guest Editor
Department of Nuclear Medicine, Charité – University Medicine Berlin, Augustenburger Platz 1, 13353 Berlin, Germany
Interests: automation; gallium-68; lutetium-177; radiopharmacy; radiochemistry

Special Issue Information

Dear Colleagues,

In this Special Issue, we would like to highlight the latest developments in automated radiolabeling processes. Many radiopharmaceuticals are produced under aseptic conditions to ensure they meet certain quality standards. Today, compliance with good manufacturing practice (GMP) in the automated production of radiopharmaceuticals is often a prerequisite for their clinical application since manual processes in sterile-drug manufacturing have the potential to introduce contamination. Additionally, radioprotection and regulatory issues have driven extensive automation of their production process.

Numerous (semi)automated synthesis platforms are available on the market to fit the individual needs of each radiopharmacy; thus, synthesis procedures may differ from each other. In this Special Issue, we encourage authors to submit original research papers that cover novel (automated) synthesis procedures, improvements in already-established protocols and reviews thereof

Dr. Sarah Spreckelmeyer
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • radiolabeling
  • automation
  • radiopharmaceuticals
  • GMP compliance
  • radiochemistry
  • radiopharmacy

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Published Papers (1 paper)

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Research

12 pages, 1426 KiB  
Article
Automated Synthesis of [68Ga]Ga-FAPI-46 on a Scintomics GRP Synthesizer
by Elisabeth Plhak, Christopher Pichler, Björn Dittmann-Schnabel, Edith Gößnitzer, Reingard M. Aigner, Susanne Stanzel and Herbert Kvaternik
Pharmaceuticals 2023, 16(8), 1138; https://doi.org/10.3390/ph16081138 - 11 Aug 2023
Cited by 3 | Viewed by 1662
Abstract
[68Ga]Ga-FAPI-46 is a radiolabelled fibroblast activation protein inhibitor that selectively binds to fibroblast activation protein (FAP), which is overexpressed by cancer-associated fibroblasts (CAFs) in the tumour microenvironment. In recent years, radiolabelled FAP inhibitors (FAPIs) are becoming increasingly important in cancer diagnostics [...] Read more.
[68Ga]Ga-FAPI-46 is a radiolabelled fibroblast activation protein inhibitor that selectively binds to fibroblast activation protein (FAP), which is overexpressed by cancer-associated fibroblasts (CAFs) in the tumour microenvironment. In recent years, radiolabelled FAP inhibitors (FAPIs) are becoming increasingly important in cancer diagnostics and also for targeted radionuclide therapy. Because of the increasing demand for radiolabelled FAPIs, automating the synthesis of these compounds is of great interest. In this work, we present a newly programmed automatic synthesis process of [68Ga]Ga-FAPI-46 on a Scintomics GRP module using two Galli Ad generators as a radionuclide source. Dedicated cassettes for the labelling of 68Ga-peptides were used without any modifications. The generators were connected via a three-way valve to the module and eluted automatically over a strong cation exchange (SCX) cartridge by using the vacuum pump of the synthesis module, eliminating the need to transfer the eluates into a separate vial. After a reaction step in HEPES buffer, the compound was purified by solid-phase extraction (SPE) over a Sep-Pak Light C18 cartridge. The evaluation of 10 routine syntheses of [68Ga]Ga-FAPI-46 resulted in a radiochemical yield of 72.6 ± 4.9%. The radiochemical purity was 97.6 ± 0.3%, and the amount of free gallium-68 and colloid was <2%. The final product fulfilled the quality criteria, which were adapted from relevant monographs of the European Pharmacopoeia (Ph. Eur.). This work presents the successful preparation of multiple doses of [68Ga]Ga-FAPI-46 in a GMP-compliant automated process for clinical use. Full article
(This article belongs to the Special Issue Automation of Radiolabeling Processes)
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